Objective:With the help of the advanced ACD Labs/AutoChrom method development software,param-eter simulation design was carried out.Based on the results of software simulation and actual investigation,an HPLC method for the determination of related impurities in safinamide mesylate raw material drug was established.Methods:A Waters Atlantis T3 column(4.6 mm ×250 mm,5 μm)was used.The phosphate buffer with a pH of 7.0 was used as mobile phase A,and acetonitrile was used as mobile phase B.Gradient elution was performed at a flow rate of 1.3 mL·min-1,the detection wavelength was 228 nm,the column temperature was 35 ℃,and the injection volume was 10 μL.Results:Impurities 1-12 in safinamide mesylate could be effectively separated from the main component.The linear ranges were 0.102 1-5.329,0.102 9-5.379 7,0.106 8-4.972 9,0.102 1-5.135,0.103 8-5.314 7,0.097 7-4.869 8,0.095 2-4.760 5,0.095 3-5.109 5,0.050 5-5.287 5,0.098 7-4.885 6,0.102 4-4.997 5,0.050 8-5.134 7 μg·mL-1,respectively.The limits of detection(LOD)were 0.051,0.051 4,0.053 4,0.051 1,0.051 9,0.048 8,0.047 6,0.047 7,0.025 3,0.049 3,0.051 2,0.025 4 μg·mL-1,and the limits of quantification(LOQ)were 0.102 1,0.102 9,0.106 8,0.102 1,0.103 8,0.097 7,0.095 2,0.095 3,0.050 5,0.098 7,0.102 4,0.050 8 μg·mL-1.The accuracy,preci-sion and durability all met the requirements.Conclusion:This method is suitable for the determination and quality control of the related substances of 12 impurities in safinamide mesylate raw materials.

Objective:With the help of the advanced ACD Labs/AutoChrom method development software,param-eter simulation design was carried out.Based on the results of software simulation and actual investigation,an HPLC method for the determination of related impurities in safinamide mesylate raw material drug was established.Methods:A Waters Atlantis T3 column(4.6 mm ×250 mm,5 μm)was used.The phosphate buffer with a pH of 7.0 was used as mobile phase A,and acetonitrile was used as mobile phase B.Gradient elution was performed at a flow rate of 1.3 mL·min-1,the detection wavelength was 228 nm,the column temperature was 35 ℃,and the injection volume was 10 μL.Results:Impurities 1-12 in safinamide mesylate could be effectively separated from the main component.The linear ranges were 0.102 1-5.329,0.102 9-5.379 7,0.106 8-4.972 9,0.102 1-5.135,0.103 8-5.314 7,0.097 7-4.869 8,0.095 2-4.760 5,0.095 3-5.109 5,0.050 5-5.287 5,0.098 7-4.885 6,0.102 4-4.997 5,0.050 8-5.134 7 μg·mL-1,respectively.The limits of detection(LOD)were 0.051,0.051 4,0.053 4,0.051 1,0.051 9,0.048 8,0.047 6,0.047 7,0.025 3,0.049 3,0.051 2,0.025 4 μg·mL-1,and the limits of quantification(LOQ)were 0.102 1,0.102 9,0.106 8,0.102 1,0.103 8,0.097 7,0.095 2,0.095 3,0.050 5,0.098 7,0.102 4,0.050 8 μg·mL-1.The accuracy,preci-sion and durability all met the requirements.Conclusion:This method is suitable for the determination and quality control of the related substances of 12 impurities in safinamide mesylate raw materials.

Objective:To learn about the current situation of prevention and control results of three-year campaign for Kashin-Beck disease (KBD) in Pingliang City, and to provide scientific basis for prevention and control of KBD.Methods:A retrospective analysis was carried out to collect the KBD surveillance data of all villages in the counties (cities, districts) affected by KBD in Pingliang City, Gansu Province during 2019 - 2020 from the "National Integrated Management System for Endemic Disease Prevention and Control (Three-year Campaign Action Management System)", including, the prevalence of children aged 7 to 12 years old, the implementation of prevention and control measures, and the case investigation, the establishment, management of health files and treatment of current patients.Results:Patients with KBD were distributed in 6 counties (cities, districts), 64 townships (towns), and 690 villages in Pingliang City, and all of them were seriously ill area. In 2019 and 2020, 40 537 and 41 053 children aged 7 to 12 years old were examined, respectively, and the clinical detection rate was 0.08% (31/40 537) and 0.03% (12/41 053), respectively; the X-ray detection rate was 0 in each year. In the dietary structure of residents in Pingliang City from 2018 to 2020, the consumption proportions of rice, flour and other diets was 15.03%, 76.63% and 8.34%, respectively, and the purchase proportion of staple food was 19.28%. From 2018 - 2020, 9 564 households and 36 282 people had been relocated from the affected areas, 4 831 children aged 7 to 12 years old had been raised in different places, 14.81% (420 914/2 842 939) of the original cultivated land had been converted to cash crops, 21.81%(620 045/2 842 939) of the original cultivated land had been converted from farmland to forest (grass), and 231 811 nutrition package for children aged 6 to 24 months had been given. A total of 6 269 KBD patients were investigated and registered, including 3 722 males and 2 547 females, with a gender ratio of 1.00 ∶ 0.68. The most clinical grading was grade Ⅰ, accounting for 78.00% (4 890/6 269), followed by grade Ⅱ (15.89%, 996/6 269) and grade Ⅲ (6.11%, 383/6 269); the age of onset was (64.57 ± 10.01) years old, ranging from 16 to 87 years old; most patients were over 50 years old, accounting for 86.57% (5 427/6 269). In 2019, 1 659 KBD patients were treated. The apparent efficiency, effective efficiency and ineffective efficiency were 25.38% (421 cases), 52.92% (878 cases) and 21.70% (360 cases), respectively. In 2020, 1 395 KBD patients were treated; the apparent efficiency, effective efficiency and ineffective efficiency were 19.50% (272 cases), 61.65% (860 cases) and 18.85% (263 cases), respectively.Conclusions:All villages in KBD area in Pingliang City have reached the elimination standard and achieved the elimination goal. We should continue to do a good job in the dynamic monitoring of the disease, strengthen the implementation of prevention and control measures and rehabilitation intervention for patients with KBD, and improve the quality of life of patients.

A total of 185 patients with type 2 diabetes mellitus (T2DM) were consisted of male group (n =95) and postmenopausal female group (n =90).The parameters of fasting plasma glucose,HbA1c,fasting insulin,fasting C peptide,homeostasis model assessment insulin resistant index (HOMA-IR) and β-cell function (HOMA-β),blood lipid,body mass index,and waist to hip ratio were collected and analyzed by Pearson correlation analysis and stepwise multiple regression analysis.The relationships between osteocalcin and these parameters were investigated.The results revealed that osteocalcin was negatively correlated with HbA1C (P＜0.05),and osteocalcin was an independent relevant factor affecting HbA1Clevels.Osteocalcin may be involved in the regulation of glucose metabolism in T2DM.